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Risk of MASLD in Adults in Romania

NCT06864845 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 5340

Last updated 2025-03-12

No results posted yet for this study

Summary

This study aims to evaluate the presence of Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) risk factors and estimate the probability of advanced liver disease in a Romanian cohort from the European Health Examination Survey (EHES). Using standardized clinical, anthropometric, and laboratory data, the study will assess metabolic and alcohol-related contributors to liver disease. The primary focus is to identify an at-risk MASLD population, characterize associated metabolic risk factors, and evaluate disease awareness through the presence of ICD-10 diagnostic codes for liver disease.

The study applies the Forns Score as a validated non-invasive tool for assessing liver fibrosis risk and incorporates the latest EASL-AASLD 2024 guidelines to define MASLD, MASH, Alcohol-Related Liver Disease (ALD), and MetALD (combined metabolic and alcohol-related liver disease). Additionally, it will explore potential underdiagnosis rates of liver disease by comparing clinical risk markers with documented diagnoses.

The study is a post hoc, cross-sectional, retrospective analysis and does not involve new data collection or patient contact. Data analysis will be performed using descriptive statistics, subgroup comparisons, and multivariate models to assess relationships between metabolic risk factors, MASLD probability, and liver disease awareness. This research will contribute to the understanding of MASLD epidemiology in Romania and inform public health strategies for early detection and prevention.

Conditions

  • Risk Factors
  • MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease

Sponsors & Collaborators

  • Transilvania University of Brasov

    collaborator OTHER

  • Internist.Ro

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-08-01
Primary Completion
2022-10-31
Completion
2022-10-31

Countries

  • Romania

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06864845 on ClinicalTrials.gov